Informations générales (source: ClinicalTrials.gov)
Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS) (CHIPPI)
Interventional
Phase 3
Centre Oscar Lambret (Voir sur ClinicalTrials)
avril 2019
août 2028
29 juin 2024
This is a phase III, multicenter, interventional and randomized study which evaluates the
use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary
Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian
cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS),
the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Anne-Sophie BATS, MD | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14076 - Caen - France | Sandrine MARTIN-FRANCOISE, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Agathe CROUZET, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud - 69495 - Pierre-Bénite - France | Naoual BAKRIN, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Christophe POMEL, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Fabrice NARDUCCI, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Frédéric MARCHAL, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Clinique Mathilde - 76100 - Rouen - France | Benoît RESCH, MD | Contact (sur clinicalTrials) | |||
| Hôpital de Hautepierre - Strasbourg - France | Chérif AKLADIOS, MD | Contact (sur clinicalTrials) | |||
| Hôpital Jeanne de Flandre - 59037 - Lille - France | Pierre COLLINET, MD, PhD | Contact (sur clinicalTrials) | |||
| ICM-Val d'Aurelle - 34298 - Montpellier - France | Pierre-Emmanuel COLOMBO, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Coriolan LEBRETON | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44800 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - 49055 - Angers - France | Romuald WERNERT, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13273 - Marseille - France | Eric LAMBAUDIE, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
Pre-eligibility criteria to be checked before surgery for pre-registration
1. Age ≥18 years and ≤ 76 years
2. Histologically proven primary epithelial ovarian carcinoma or fallopian tube
carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma,
clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma)
3. Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage
III
4. Patient eligible for
1. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/-
bevacizumab or other targeted therapy
2. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/-
bevacizumab or other targeted therapy, with or without planned adjuvant
chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant
chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in
case of chemotherapy without bevacizumab, and in a time interval of 4 to 6
weeks if chemotherapy is combined with bevacizumab. The patient remains
eligible for the study if surgery is delayed beyond the recommended time
interval.
5. WHO (World Health Organization Performance Status) ≤ 2
6. Physical status score ASA (American Society of Anesthesiologists) ≤ 2
7. Adequate bone marrow and renal function, as evidenced by the following tests
performed within 7 days prior to surgery:
- Absolute Neutrophil Count (ANC) ≥1,500/mm3
- Platelets ≥100,000/mm3
- Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper
limit of normal (ULN) (≤5.0 × ULN in case of liver metastases)
- Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease)
- Creatinine clearance ≥ 60 mL/ min
8. Negative serum pregnancy test within 7 days prior to surgery for women of
childbearing potential. For non-menopausal women, if no hysterectomy is planned,
willing to accept the use of an effective contraceptive regimen during the treatment
period and at least 6 months after the end of treatment (surgery or adjuvant
chemotherapy)
9. Absence of contraindication to receive the products used in this study (cisplatin
and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most
recent SmPC (Summary of Product Characteristics) of these products
10. Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits and examinations including
follow-up
11. Signed written informed consent
12. Patient covered by the French or Belgian "Social Security" regime Criteria to be
checked per-operatively for confirmation of enrolment and randomization
13. Residual disease after surgery (cytoreduction score CC) CC-0 (no macroscopic
residue) or CC-1 (residue < 2.5 mm)
14. Per-operative hemorrhage < 2.5 L
15. Strictly less than 3 digestive resections performed during surgery
16. Diuresis maintained during surgery, without oliguria or anuria (per-operatory
diuresis ≥ 0,5 mL/ kg/ h)
Pre-eligibility criteria to be checked before surgery for pre-registration
1. Age ≥18 years and ≤ 76 years
2. Histologically proven primary epithelial ovarian carcinoma or fallopian tube
carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma,
clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma)
3. Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage
III
4. Patient eligible for
1. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/-
bevacizumab or other targeted therapy
2. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/-
bevacizumab or other targeted therapy, with or without planned adjuvant
chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant
chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in
case of chemotherapy without bevacizumab, and in a time interval of 4 to 6
weeks if chemotherapy is combined with bevacizumab. The patient remains
eligible for the study if surgery is delayed beyond the recommended time
interval.
5. WHO (World Health Organization Performance Status) ≤ 2
6. Physical status score ASA (American Society of Anesthesiologists) ≤ 2
7. Adequate bone marrow and renal function, as evidenced by the following tests
performed within 7 days prior to surgery:
- Absolute Neutrophil Count (ANC) ≥1,500/mm3
- Platelets ≥100,000/mm3
- Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper
limit of normal (ULN) (≤5.0 × ULN in case of liver metastases)
- Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease)
- Creatinine clearance ≥ 60 mL/ min
8. Negative serum pregnancy test within 7 days prior to surgery for women of
childbearing potential. For non-menopausal women, if no hysterectomy is planned,
willing to accept the use of an effective contraceptive regimen during the treatment
period and at least 6 months after the end of treatment (surgery or adjuvant
chemotherapy)
9. Absence of contraindication to receive the products used in this study (cisplatin
and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most
recent SmPC (Summary of Product Characteristics) of these products
10. Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits and examinations including
follow-up
11. Signed written informed consent
12. Patient covered by the French or Belgian "Social Security" regime Criteria to be
checked per-operatively for confirmation of enrolment and randomization
13. Residual disease after surgery (cytoreduction score CC) CC-0 (no macroscopic
residue) or CC-1 (residue < 2.5 mm)
14. Per-operative hemorrhage < 2.5 L
15. Strictly less than 3 digestive resections performed during surgery
16. Diuresis maintained during surgery, without oliguria or anuria (per-operatory
diuresis ≥ 0,5 mL/ kg/ h)
1. Benign disease, borderline disease, non epithelial ovarian carcinoma or
carcinosarcoma
2. Cirrhosis
3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients
in the formulation
4. Auditory impairment
5. Dehydration or intercurrent disease that contraindicates hyperhydration (including
cardio-respiratory disease)
6. Other uncontrolled intercurrent disease including, but not limited to: diabetes;
hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or
severe gastrointestinal (associated with diarrhea) chronic disease
7. Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy
(excluding alopecia)
8. Concomitant treatment with prophylactic phenytoin
9. Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days
prior to inclusion (and, if patient is enrolled, up to 30 days after the last
administration of study treatment)
10. Pregnant or breastfeeding woman
11. Psychiatric illness or social situation that would limit compliance with study
requirement, substantially increase the risk of side effects, or compromise the
ability of the patient to give written informed consent
12. Inability to comply with medical follow-up of the trial (geographical, social or
psychic reasons)
13. Person under guardianship